Acumen Pharmaceuticals has concluded enrolment for its multi-centre, double-blind Phase II ALTITUDE-AD trial of humanised monoclonal antibody sabirnetug (ACU193) for treating individuals with early Alzheimer’s disease.
Sabirnetug claims to be the first antibody to show selective engagement of amyloid beta oligomers (AβOs), a toxic form of amyloid beta that plays a critical role in the early stages of the illness.
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The ALTITUDE-AD trial, which commenced last year, is a randomised, placebo-controlled study that has enrolled 542 subjects across Canada, the EU, the US, and the UK.
Subjects in the trial were given one of two doses of 35mg/kg or 50mg/kg of the antibody or a placebo, with a primary endpoint focusing on changes in the Integrated Alzheimer’s Disease Rating Scale (iADRS) during the 18-month period.
Secondary endpoints of the trial encompass the Clinical Dementia Rating – Sum of Boxes scale (CDR-SB), Alzheimer’s Disease Assessment Scale-cognition sub-scale (ADAS-Cog 13 (ADAS-Cog13), Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL), and several biomarkers of the disease.
Standard safety measures and magnetic resonance imaging (MRI) evaluations are also integral parts of the trial. Following the completion of the double-blind phase, subjects will have the option of continuing in an open-label extension.
The company has reported that it is on track to announce topline outcomes, including safety and efficacy data, by late 2026.
In the Phase I INTERCEPT-AD trial, the antibody was found to be generally “well-tolerated” and demonstrated a dose-dependent target engagement.
Acumen Pharmaceuticals CEO and president Daniel O’Connell said: “We are pleased to complete the enrolment for our Phase II ALTITUDE-AD trial of sabirnetug. Achieving this milestone is a testament to the significant interest in our approach from both patients and the scientific community, and we are grateful to all the participants, investigators and trial sites, and our clinical team for enabling us to complete enrolment efficiently.”
